Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04485299

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

Condition or Disease	Intervention/Treatment	Phase
Hypersensitivity Dentin Sensitivity	Drug: Bifluorid 10 ,VOCO Drug: Sodium Fluoride 5% Dental Varnish	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bifluorid 10 varnish Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.	Drug: Bifluorid 10 ,VOCO NaF and CaF 10 % Other Names: Bifluorid 10
Active Comparator: sodium fluoride varnish Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.	Drug: Sodium Fluoride 5% Dental Varnish 5% NaF Other Names: conventional sodium fluoride varnish

Arm

Intervention/Treatment

Experimental: bifluorid 10 varnish

Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.

Drug: Bifluorid 10 ,VOCO

NaF and CaF 10 %

Other Names:

Bifluorid 10

Active Comparator: sodium fluoride varnish

Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.

Drug: Sodium Fluoride 5% Dental Varnish

5% NaF

Other Names:

conventional sodium fluoride varnish

Outcome Measures

Primary Outcome Measures

Dentin hypersensitivity [pre-intervention]
measurement of dentin hypersensitivity by VAS scale
Dentin hypersensitivity [2 min]
measurement of dentin hypersensitivity by VAS scale
Dentin hypersensitivity [1 week]
measurement of dentin hypersensitivity by VAS scale
Dentin hypersensitivity [4 weeks]
measurement of dentin hypersensitivity by VAS scale
Dentin hypersensitivity [8 weeks]
measurement of dentin hypersensitivity by VAS scale

Secondary Outcome Measures

Dentinal tubule occlusion [Pre-intervention]
Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Dentinal tubule occlusion [8 weeks]
Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy patient with free medical history.
Age range 18-60 years old.
Good oral hygiene
Patients suffering from pain due to dentin hypersensitivity.
Patient with sound first molar .

Exclusion Criteria:

Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months.
Patient wearing orthodontic appliance.
Patient with teeth having a painful condition involving the pulp and periapical region.
Patients who had allergy to materials will be used in the study.
Pregnancy.
Patient who does not consent to participation.
Patient who does not attend to the follow up.
A patient who has a carious first molar.